Laboratory test tracking

One of the leading causes of malpractice suits is the failure or breakdown of the laboratory test workflow. An integral part of this workflow is test tracking, which encompasses procedures from the point of test requests, sample collections, analyses, reports, and patient treatment plans. The test tracking system is a mechanism that assures positive identification of a specimen throughout the ordering, collecting, processing, testing, and reporting phases.

A good test tracking system will greatly reduce the frequency of errors due to specimen mix-ups that lead to, among other things, reporting a result that belongs to someone else or loss of test results. This type of confusion can have serious consequences for patients and the laboratory. In most laboratories, test tracking is integrated within the larger laboratory information system (LIS), an automated workflow management system that records, manages, and stores clinical laboratory data.

The implementation of a test tracking system

The goals of implementing a tracking system are to enable automation, improve efficiency, facilitate traceability, standardize workflow, and enhance patient

safety. It is important to remember that tracking systems track the bar codes, not the specimens themselves, therefore, it is necessary to ensure that the correct barcodes are used and they remain associated with the asset (which includes requisition forms, specimens in tubes, or on slides and blocks) they represent.

The first step in tracking is the association of each asset to be tracked with a machine-readable identifier. The identifier is typically a bar code that allows for rapid and accurate entry of data into the tracking system, capturing information such as date/time, the location (lab) at which the asset was scanned, or the type of specimen e.g. hematological, tissue, urine, etc.

There are three major technical domains in the implementation of a test tracking system;

• Methodology
• Technology
• The lab culture

Methodology

It is important to streamline all the procedures involved in the testing process before the implementation begins. This involves the outline of all the workflows, from obtaining the requisition form to the patient results report. Customization is done at this stage on the test tracking, depending on the workflow, which is in turn dependent on the type of lab test carried out.

Technology

The most common test tracking technology is the use of barcodes but recently, the more advanced radio frequency identification tags (RFID) are also being incorporated. Bar codes are machine-readable data representation patterns consisting of bars, blocks, and spaces while the  RFID are small electronic devices that when affixed to an asset can store unique codes or characters about that specimen.

There is a variety of software to choose from, although the use of a tracking module already integrated into the lab’s LIS is more convenient. As for the hardware (devices such as scanners to read barcodes and radio-frequency signals, printers for barcode label printing), computers are necessary and they should be easily accessible to stations where they are required.

The lab culture

For successful implementation of test tracking programs, there is a need for a ‘’buy-in’’ from all users because human non-compliance, rather than technological issues, is frequently the cause for the failure of tracking solutions. Thorough training of laboratory staff is necessary and individuals will need to overcome training curves and understand the importance of compliance with the tracking system and effective patient care.

Components of a good test tracking system

A proper test tracking system should include three components;

• Test requisition
• Test record
• Test report

Test requisition

The test requisition captures the patient’s information and the physician’s requests.

It contains;

• Full name of the patient. An additional way of identifying the patient is needed when the patient has a common or duplicate name.
• Chart/account number/barcode – This is a unique preprinted number or code stamped on the requisition that will uniquely link the patient to their respective specimen and results.
• Name and address of the person requesting the test.
• A contact person to whom to report “panic” or life-threatening test results. This person is usually the physician who ordered the test unless otherwise specified.
• Name of the test(s) requested.
• Date and time of specimen collection.
• Any clinical information that is relevant to the test results. For example, the age, gender, date, and time of the last dose of medication, etc.

Test record

This is a record of all patient specimens as they are being collected, received, processed, and tested by the laboratory. This ensures that all records of patient specimen collections and test analyses are under one file. The test record can be a single form divided into columns with each new patient specimen entered in a new row, computer or billing logs, or a filing system for requisitions, records, and reports.

It should include;

• The patient’s full name.
• The date and time the specimen was received.
• The condition of the specimen – This is to verify whether the specimen meets the laboratory’s criteria for specimen acceptability.
• Identity of the person performing the test – This can be name initials or identification codes.
• Records of specimen tests.

The test report

The test report is the final form that is sent to the physician or any other person who ordered the test. Some laboratories require the final report to be reviewed by a supervisor before it is sent. If the laboratory does not have access to the patient’s chart, the original report or an exact duplicate test report should be filed in the laboratory so that it can be easily retrieved.

The test report should include:

• Name and address of the testing laboratory.
• Test results with units of measure.
• .The date the report was released from the laboratory.
• The normal range of values of the tested parameter with units of measure.

Importance and benefits of test tracking

There are several advantages to implementing a tracking system. This includes;

• Its ability to help eliminate labeling errors and maintain optimal patient safety, thereby reducing medical-legal liability.
• Tracking data can be used to locate the history of any specimen, making it possible to investigate any problems associated with its analysis.
• It can provide up-to-the-minute information about the current status of a patient’s specimen or documentation like reports.
• Tracking specimens in the laboratory can provide real-time detection of workflow bottlenecks. For example, individual user productivity can be monitored, if needed, by determining how many specimens the user processes and over what period of time.
• Tracking systems provide auditing capabilities, posting events for each specimen or report, generating audit trails, and allowing for subsequent workflow analysis.
• The tracking system may include improved logistics (e.g., better management of inventory, such as reagents) by automatically capturing data with a timestamp directly into the LIS. These metrics can be analyzed as part of an overall quality management program.

Quality assurance on test tracking

The laboratory director is in charge of periodically evaluating the test tracking system to be sure that it is being followed and that it is preventing specimen mix-ups. This is part of the laboratory’s quality assessment and assurance program, it should be a well-documented process, whose aim is to point out and rectify areas of weaknesses in the system.

The areas to be evaluated and audited include;

• Test requisitions – This should be reviewed for completeness, relevance, and legibility.
• Specimen labeling – Evaluation should ensure that the labeling complies with outlined standards and that the barcode generation is error-free.
• Storage system – Specimen storage periods follow specific guidelines depending on the type of specimen, for example, Immunological and hematological specimens are stored typically for 2 years while pathology samples (tissue blocks) are stored for ten years.
• Test records and test reports – Evaluation of ease of access to stored records measures the efficiency of the tracking system.
• Staff compliance – This verifies that all the staff involved in specimen handling, test analysis, and report writing have the necessary training and follow the laid out guidelines of test tracking.

Conclusion

The mishandling of the test workflow and delays that are caused by misplaced samples and test results have far-reaching repercussions. For the patients and their relatives, poor test result handling can lead to distress, delayed treatments, unsatisfactory care experiences, the inconvenience of additional appointments to repeat blood tests or make complaints. Even worse, it can cause harm to patients due to delayed clinical judgments and treatment decisions. On the other end, hospitals and physicians can experience aftermaths ranging from loss of trust by patients to litigation claims and sanctions by medical regulators. A good test tracking system minimizes these risks by ensuring proper specimen and result identification and an overall increase in efficiency of the testing process.

References

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2. Pantanowitz L, Mackinnon AC, and Sinard JH. Tracking in Anatomic Pathology. Arch Pathol Lab Med,  2012 137;1798-1810
3. Epner PL, Gans JE, and Graber ML. When diagnostic testing leads to harm: a new outcomes-based approach for laboratory medicine. BMJ Qual Saf, 2013 22; ii6–ii10
4. Hanna  MG and Pantanowitz L. Bar Coding and Tracking in Pathology. Sur Pathol,  2015 8; 123-135